South Africa: The Great Pharmaceutical Patent Debate

In recent news, the TAC (Treatment Action Campaign) has called
on government to revise the Patents Act to reduce the patent
protection available to pharmaceutical inventions, which the
organisation believes is responsible for the high cost of medicines
and a delay in the availability of generic medicines.

The organisation refers to the Doha Declaration, which has been
signed by South Africa as a member of the World Trade Organisation,
to support its call.

There is no denying that the impact of diseases such as
HIV/AIDS, tuberculosis and malaria on developing countries,
including South Africa has been devastating. However,
amendment of the Patents Act is not necessarily the best or more
efficient way forward to deal with this health crisis. In
fact, there are already mechanisms in place in both the Patents Act
and the Medicines and Related Substances Control Act which address
the very concerns raised in the Doha Declaration and provide
mechanisms for government to step in and ensure affordable
medicines. The problem is that government has not yet been
proactive in utilising these mechanisms.

The Doha Declaration, which was signed in 2001 provides that
member countries are not prevented by membership of the TRIPS
Agreement from taking measures to protect public health and that
the TRIPS Agreement can be interpreted to protect public health and
to promote access to medicines for all. Certain mechanisms
for doing so are set out in the Doha Declaration including: the
right of member countries to grant compulsory licences and the
freedom to determine the grounds upon which such licences are
granted; and the right to determine what constitutes a national
emergency in order for the government to exercise its
"walk-in" rights and an affirmation that HIV/AIDS,
tuberculosis, malaria and other epidemics, can represent a national
emergency.

The South African Patents Act has a number of sections which may
be used by government (or other parties) to give effect to the
measures described in the Doha Declaration in relation to the
public health issues and access to medicines.

Section 4 of the Patents Act sets out that a Minister of State
can use an invention for public purposes on agreed upon conditions,
or if there is no agreement, on conditions as are determined by the
Commissioner of Patents on application by the Minister and after
hearing the patentee. There are no grounds stipulated here,
merely that the invention must be used for public
purposes. However, this section has not to date been
utilised by the State.

Section 78 of the Patents Act sets out that a Minister may on
behalf of the State, acquire any invention or patent on agreed upon
terms and conditions. No grounds are stipulated, only that
conditions must be agreed upon between the parties. Again,
the State has to date not pursued such an acquisition of a patent
or invention.

Section 56 of the Patents Act sets out the grounds for an
applicant to be able to apply for a compulsory licence from the
Commissioner of Patents in regard to a patented invention where
there has been an abuse of rights by the patentee. This
section in particular, pertains to the compulsory licence
provisions provided for in the Doha Declaration.

Of particular relevance to the issue of access to affordable
medicines are subsections (1)(c) and (e). In specific,
subsection (c) provides that a compulsory licence can be applied
for in a case where the demand for the patented article in South
Africa is not being met to an adequate extent and on reasonable
terms. Our courts have indicated that "adequate
extent" means sufficient for the needs of South Africa and
that a lack of "reasonable terms" may be evidenced by
public dissatisfaction with the prices. Although the
decisions are made by the Commissioner of Patents on a case-by-case
basis to award a compulsory licence, it seems that a lack of access
to affordable medicine would meet the requirements for such a
compulsory licence application.

Although more limited in application, subsection (e) provides
that an applicant for a compulsory licence may do so on the ground
that the price of the patented article is excessive compared to
country of manufacture where the demand for the patented article in
South Africa is being met by importation but where the price
charged in the South Africa is excessive in comparison to countries
where the patented article is manufactured and there is no good
reason for the substantially higher price.

Despite these provisions, very few applications for compulsory
licences have been brought to the Commissioner of Patents.

Furthermore, the Medicines and Related Substances Control
Act in section 15C sets out measures which can be applied by the
Minister of Health to ensure supply of more affordable
medicines. Firstly, the Minister can, despite the provisions
of the Patents Act, prescribe that certain rights of an owner of a
medicine registered in South Africa are limited and do not extend
to acts in respect of the medicine. In other words, acts of
infringement by a third party when pertaining to provision of
access to affordable medicines can be allowed by the Minister of
Health in terms of this section.

Secondly, in a more limited provision, the Act also sets out
that the Minister can prescribe conditions on which a generic
medicine can be imported by a person who is not the holder of the
registration certificate for a registered medicine. However,
the medicine must have originated from the site of manufacture of
the original manufacturer.

The reality is that amendment of legislation tends to be a
lengthy process and depending on the quality of the drafting can
often have unintended or unforeseen consequences. As
indicated, there are a number of existing mechanisms that can
already be used and I believe that government should be lobbied to
be more proactive in putting these mechanisms to use to provide
more affordable access to medicines, which would in turn be in
keeping with our undertaking as a signatory to the Doha
Declaration.

The content of this article is intended to provide a general
guide to the subject matter. Specialist advice should be sought
about your specific circumstances.

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